Evidence map›Paper›PMID 32219630›Full record

Trial reportInternational journal of clinical oncology2020

Phase II study of 5-fluorouracil-leucovorin plus bevacizumab for chemotherapy-naïve older or frail patients with metastatic colorectal cancer (OGSG 0802).

Takashi Ohta, Takeshi Kato, Hisato Kawakami, Yasuhiro Miyake, Masahiro Goto, Shigeyoshi Iwamoto, Toshio Otsuji, Masato Nakamura, Naotoshi Sugimoto, Shu Okamura and 8 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Takashi OhtaDepartment of Clinical Oncology, Kansai Rosai Hospital, Amagasaki, Japan.
Takeshi KatoDepartment of Surgery, Osaka National Hospital, Osaka, Japan.
Hisato KawakamiDepartment of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka, 589-8511, Japan. kawakami_h@med.kindai.ac.jp.
Yasuhiro MiyakeDepartment of Surgery, Osaka Minato Central Hospital, Osaka, Japan.
Masahiro GotoCancer Chemotherapy Center, Osaka Medical College, Takatsuki, Japan.
Shigeyoshi IwamotoCancer Center, Aichi Medical University, Nagakute, Japan.
Toshio OtsujiDepartment of Internal Medicine, Dongo Hospital, Yamatotakada, Japan.
Masato NakamuraComprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.
Naotoshi SugimotoDepartment of Clinical Oncology, Osaka International Center Institute, Osaka, Japan.
Shu OkamuraDepartment of Surgery, Suita Municipal Hospital, Suita, Japan.
Masahito KotakaDepartment of Surgery, Sano Hospital, Kobe, Japan.
Masaki TsujieDepartment of Surgery, Tondabayashi Hospital, Tondabayashi, Japan.
Yukihiko TokunagaDepartment of Surgery, Japan Post Kyoto Teishin Hospital, Kyoto, Japan.
Hideyuki MishimaCancer Center, Aichi Medical University, Nagakute, Japan.
Taishi HataDepartment of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
Toshio ShimokawaDepartment of Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
Yukinori KurokawaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Taroh SatohDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOlder or frail patients are often underrepresented in clinical trials for metastatic colorectal cancer (mCRC). We here assessed the efficacy and safety of 5-fluorouracil (5-FU)-leucovorin plus bevacizumab in such patients.

methodsThe study (OGSG 0802) was designed as a single-arm, open-label, multicenter phase II trial. Eligible patients had mCRC and at least one of the following: an age of ≥ 65 years, an Eastern Cooperative Oncology Group performance status of 1 or 2, a serum albumin level of ≤ 3.5 g/dL, incompatibility with oxaliplatin or irinotecan, and a history of abdominal or pelvic radiotherapy. Patients received 5-FU (600 mg/m

resultsForty-one patients were enrolled and eligible. Median age was 76 years (range 56-90 years), and 51% of patients had a performance status of 0. The ORR was 36.6% [95% confidence interval (CI) 22.1-53.1%], median PFS was 9.4 months (95% CI 7.4-17.7 months), and median OS was 24.0 months (95% CI 19.9 months-not reached). The most common treatment-related adverse events of grade ≥ 3 were neutropenia (24%), anorexia (10%), leukopenia (7%), and mucositis/stomatitis (7%). There were no treatment-related deaths.

conclusionWeekly 5-FU-leucovorin with biweekly bevacizumab may be a tolerable and effective treatment option for older or frail patients with mCRC.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsFemaleFluorouracilFrail ElderlyHumansIrinotecanLeucovorinMaleMiddle AgedOxaliplatinProgression-Free SurvivalTreatment OutcomeBevacizumabFluorouracilIrinotecanLeucovorinOxaliplatin5-fluorouracilBevacizumabFrailMetastatic colorectal cancerOlder

Identifiers

PMID32219630

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.